Spinal Arthrodesis and Spinal Arthroplasty Database Study | NCT01979094

Studies
Spinal Arthrodesis and Spinal Arthroplasty Database Study

NCT01979094

Sponsor

Stephanus Viljoen

Status

Terminated

Last Update Posted

Mar 5, 2024Actual

Enrollment

1,296Actual

Phase

Not provided

Conditions

Spine Condition

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Process changes. New data base will be activated

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Jan 4, 2024Actual

Completion Date

Jan 4, 2024Actual

First Submitted Date

Oct 24, 2013

First Submission Date that Met QC Criteria

Nov 7, 2013

First Posted Date

Nov 8, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2024

Last Update Posted Date

Mar 5, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To collect and organize data into a repository for future research.

Detailed Description

To collect and organize data into a repository from the Principal Investigator's (H. Francis Farhadi, MD, PhD) patients who are undergoing spinal arthrodesis and/or spinal arthroplasty procedures at Ohio State University for future research, as yet to be identified. This comprehensive database of patients will allow for gathering of relevant information for potential future research use.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,296Actual

Label	Type	Description	Intervention Names
spinal arthrodesis and/or arthroplasty procedures

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical prospective review- Prospective Database study for future studies	Collecting clinical measurements. Examples of these clinical measurements are the VAS Pain Scale, SF-36, NDI, and ODI.	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must have had or will undergo a spinal arthrodesis and/or spinal arthroplasty procedure at Ohio State University

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Spinal arthrodesis and/or spinal arthroplasty can be performed through either anterior, posterior, or lateral approaches for a variety of traumatic, degenerative, or deformity conditions.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
H. Francis Farhadi, MD, PhD	Ohio State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Ohio State Unviersity		Columbus	Ohio	43210	United States